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Evaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568707
Recruitment Status : Unknown
Verified February 2021 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 29, 2020
Last Update Posted : February 25, 2021
Sponsor:
Collaborator:
Brain & Spine Institute (ICM)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.

Condition or disease Intervention/treatment Phase
Covid19 Neurologic Manifestations Psychiatric Manifestations Other: blood sample Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : October 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Covid-19 infection
Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period
 Other: blood sample
blood sample for serum (serology, biomarkers) and DNA


Outcome Measures
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Primary Outcome Measures :
  1. dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients [ Time Frame: 12 months ]
    dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients


Secondary Outcome Measures :
  1. Serum neurofilaments [ Time Frame: 12 months ]
    Neurodegenerative markers (e.g., neurofilaments) associated with a neurological or psychiatric manifestation of Covid-19 infection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Age over 18 yo
  2. Patient having presented or presenting a Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period

  3. And patient with:

    1. a neurological or psychiatric manifestation de novo during or after the Covid-19 infection and/or
    2. either a chronic neurological or psychiatric pathology
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568707


Contacts
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Contact: Céline LOUAPRE, MD 1 42 16 57 66 ext +33 celine.louapre@aphp.fr
Contact: Jean-Christophe CORVOL, MD,PHD 1 42 16 57 66 ext +33 jean-christophe.corvol@aphp.fr

Locations
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France
Hôpital Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Céline LOUAPRE, MD    1 42 16 57 66 ext +33    celine.louapre@aphp.fr   
Principal Investigator: Céline LOUAPRE, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Brain & Spine Institute (ICM)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04568707    
Other Study ID Numbers: APHP200845
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19
neurological disease
Multiple Sclerosis
psychiatric disease
biology,
 biocollection,
biomarkers,
DNA,
Parkinson's Disease
Additional relevant MeSH terms:
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COVID-19
Nervous System Diseases
Neurologic Manifestations
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases